Health Condition 1: null- Rheumatoid arthritis Health Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement Health Condition 3: M060- Rheumatoid arthritis without rheumatoid factor
Conditions
Interventions
Intervention1: Curcumin - piperine tablet: Curcumin - piperine tablet
Dose - 1gram twice daily for 12 months
Control Intervention1: Placebo: 1 gram bd
Sponsors
Dr Padmanabha Shenoy D
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed cases of rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria On conventional DMARDs for at least last six months. On sustained remission based on DAS 28 (DAS 28 Documented remission status at a minimum of two consecutive visits during last 6 months .
Exclusion criteria
Exclusion criteria: Having other associated rheumatological diseases Functional class IV Abnormal liver function (defined as AST/ALT > 3 X upper normal limit ) and active hepatits/cirrhosis Abnormal renal function / chronic renal failure ( S. creatinine � 2mg/dl) Those who are currently on curcumin supplements Known allergic reaction to curcumin Major comorbidities like severe hypertension , uncontrolled diabetes mellitus , severe respiratory or cardiovascular disease , malignancy Current or past use of biologics Current use of Warfarin Subjects with acute episodes of cholecystitis within last few months Pregnant and lactating women Psychiatric or mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of flare and time to flare in placebo and curcumin arm will be comparedTimepoint: 1 YEAR | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Cytokine levels ( MBDA assay: multibiomarkerdisease activity (MBDA) score ) which is a validated score of 12 cytokines will be done in patients who have flared and those who are in remission to see which are the cytokines suppressed by curcumin to maintain remission 2.Change in DAS 28 in placebo and curcumin arm 3.Change in HAQ DI in placebo and curcumin arm Timepoint: 1 YEAR | — |
Countries
India
Contacts
Public ContactDr Padmanabha Shenoy D
Centre for arthritis and Rheumatism Excellence (CARE), Sree Sudheendra Medical Mission
Outcome results
None listed